EU enforces new tobacco retailing regulations

The Europe Union (EU) is not quite following the Australian lead on new tobacco legislation with its new regulations which came effect on 20 May 2016.

Rather than following the Australian laws which introduced plain packaging, the EU’s ‘Tobacco Product Directive’ stipulates that cigarette packs only be covered in at least 65 per cent graphic health warnings.

The European laws are also different in that e-cigarettes come with health warnings.

In describing the new tobacco laws, EU Commissioner for Health and Food Safety, Vytenis Andriukaitis, made a controversial statement in which he compared the dangers of smoking to the dangers of terrorism.

“Two terrorist attacks in Brussels are very dangerous, but of course 700,000 premature deaths are also very dangerous,” he said.

In a separate statement, the commissioner said the Directive aimed to reduce the number of smokers in the EU but especially hoped to discourage youth from taking up the habit.

“I congratulate the countries that have already transposed the Directive into national law, and encourage an effective enforcement of the new rules in all Member States without delay,” Andriukaitis said.

“A reduction in tobacco consumption of just 2% translates into annual healthcare savings of approximately €506 million for the EU,” he said.

The changes under the Directive include:

Larger and mandatory pictorial health warnings:

Graphic health warnings with photos, text and cessation information will cover 65% of the front and the back of cigarette and roll-your-own tobacco (RYO) packs(**). Depicting the social and health impacts of smoking, the warnings are designed to discourage people from smoking or encourage them to quit. The warnings are grouped in three sets, to be rotated every year, to ensure that they retain their impact for as long as possible. The design of the warnings on cigarettes and RYO tobacco are laid out in a Commission Implementing Decision. See themock-up of the new cigarette packs.

Ban on cigarettes and RYO with characterising flavours:

Cigarettes and RYO tobacco products may no longer have characterising flavours such as menthol, vanilla or candy that mask the taste and smell of tobacco(***). In the case of products with more than a 3% market share (e.g. menthol), the ban will apply as of 2020.

A procedure for determining whether a tobacco product has a characterising flavour has been established, and an independent advisory panel will be set up to assist the Commission and Member States in this respect.

Replacement of TNCO labelling:

The tar, nicotine and carbon monoxide (TNCO) labelling on cigarettes and RYO tobacco will now be replaced with an information message that informs consumers that ‘Tobacco smoke contains over 70 substances known to cause cancer.’ Research has shown that TNCO labelling is misleading to consumers as it makes them believe that some products are less risky to their health. The new information message will more accurately reflect the true health consequences of smoking.

No more promotional or misleading packages:

Cigarette packs must have a cuboid shape to ensure visibility of the combined health warnings. Slim packs and other irregular shaped packs will no longer be allowed. Packs containing less than 20 cigarettes are also banned. Packs of 10, which are particularly appealing to young age groups with limited spending power, will therefore, disappear from the market. Promotional and/or misleading features or elements are not allowed on tobacco packages. References to lifestyle benefits, taste or flavourings, special offers, suggestions that a particular product is less harmful than another, or has improved biodegradability or other environmental advantages, will no longer be possible.

Mandatory electronic reporting on ingredients:

To gather more information on the ingredients contained in tobacco products and their effects on health and addiction, manufacturers and importers of tobacco products are required to report on ingredients in all products they place on the EU market through a standardised electronic format. Certain frequently used substances where there are initial indications to suggest that they contribute to the toxicity, addictiveness or result in characterising flavours in cigarettes and RYO tobacco will be subject to more detailed reporting requirements.

Safety and quality requirements for e-cigarettes

The Tobacco Products Directive does not ban e-cigarettes. See here to correct any other misconceptions about what will change. Instead, for the first time, certain safety and quality requirements have been introduced for e-cigarettes containing nicotine. First and foremost, because nicotine is a toxic substance, the Directive sets maximum nicotine concentrations and maximum volumes for cartridges, tanks and nicotine liquid containers. E-cigarettes should be child-resistant and tamper proof and have a mechanism that ensures refilling without spillage to protect consumers. E-cigarette ingredients must be of high purity and e-cigarettes should deliver the same amount of nicotine for puffs of the same strength and duration.

Packaging and labelling rules for e-cigarettes:

Health warnings for e-cigarettes become mandatory advising consumers that e-cigarettes contain nicotine and should not be used by non-smokers. Packaging must also include a list of all ingredients contained in the product, information on the product’s nicotine content and a leaflet setting out instructions for use and information on adverse effects, risk groups and addictiveness and toxicity. Promotional elements are not allowed on e-cigarette packaging and cross-border advertising and promotion of e-cigarettes is prohibited.

Monitoring and reporting of developments related to e-cigarettes

As e-cigarettes are a relatively new product for which evidence is only starting to emerge, the Directive lays down monitoring and reporting requirements for manufacturers and importers, Member States and the Commission:

E-cigarette manufacturers mustnotify Member States of all products they place on the market and report annually to them on sales volumes, consumer preferences and trends.

Member State authorities will monitor the market for any evidence that e-cigarettes lead to nicotine addiction or to tobacco consumption, especially in young people and non-smokers.

The Commission will also present to the European Parliament and the Council the developments on e-cigarettes in its implementation report to be produced after five years.

Possibility to ban cross-border distance sales:

EU countries may prohibit cross-border distance sales of tobacco products, which give consumers –including the very young – access to products that do not comply with the Directive. Should an EU country choose this option, the retail outlets in question cannot supply their products to consumers located in that country. Even if a Member State does not ban such sales, retail outlets must register with the competent authorities, both in the country where they are located, and in the country where they plan to sell their products.

Measures to combat illicit trade:

New measures intended to combat the illegal trade in tobacco products include an EU-wide tracking and tracing system for the legal supply chain and a security feature composed of visible and invisible elements (e.g. holograms) which should help law enforcement bodies, national authorities and consumers detect illicit products. These measures will be introduced for cigarettes and roll-your-own tobacco in 2019 and to tobacco products other than cigarettes and roll-your-own tobacco in 2024.